title: Institutional corruption of pharmaceuticals and the myth of safe and effective drugs.
abstract: Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA's prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication; independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few, if any, new clinical benefits; and the creation of a National Drug Safety Board.
authors.affiliation: Fellow for 2012-2013 at the Edmond J. Safra Center for Ethics at Harvard University in Cambridge, MA. Teaching health policy for 12 years at York University in Toronto, ON. Research fellow at Harvard Medical School and a lecturer on law at Bentley University in Waltham, MA.
authors.forename: Donald W
authors.initials: DW
authors.lastname: Light
authors.forename: Joel
authors.initials: J
authors.lastname: Lexchin
authors.forename: Jonathan J
authors.initials: JJ
authors.lastname: Darrow
mesh_terms: D003257:Consumer Product Safety; D004345:Drug Industry / Q000941:ethics; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D011050:Policy Making; D011358:Product Surveillance, Postmarketing; D011634:Public Health; D015871:Scientific Misconduct; D014481:United States